Influence of Probiotics Administration Before Liver Resection in Liver Disease

NCT02021253 | Completed

• 1 other identifier: 2012/130/HP
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Surgical resection is one of the curative treatment modalities for HCC. Limits are postoperative septic and liver functional complications related to an increase in bacterial translocation and systemic endotoxemia. Bacterial translocation is a passage of bacteria and bacterial degradation products from the intestine to the portal circulation. The endotoxemia secondary to bacterial translocation, stimulates endothelial production of nitric oxide (NO). NO is also a potent inducer of membrane instability, responsible for an increase in the permeability of the vascular endothelium and intestinal mucosa, possibly contributing to a worsening of bacterial translocation. Probiotics are live microorganisms which when administered in adequate amounts, provide a health benefit on the host ((Health and Nutritional Properties of Probiotics in Food Including Powder Milk with Live Lactic Acid Bacteria - Cordoba Argentina October 2001). Data from experimental and clinical literature show a significant effect of probiotics on the improvement of liver function and a decrease in infectious complications in patients with chronic liver disease. The proposed study would evaluate the effect preventive and therapeutic in a population of surgical patients, in whom the intestinal portal and hepatic inflammation promotes postoperative complications.

Conditions

Liver Fibrosis; Liver Cirrhosis; Permeability; Increased; Hepatocellular Carcinoma

Keywords

Endotoxemia; Probiotic; Leaky gut; Gut permeability; Liver cirrhosis; Liver fibrosis; Hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• Area under the plasma concentration versus time curve (AUC) of endotoxins circulating levels

  -12, 3, 12,24, 72, 120 hours at time of surgery

Study Arms (2)

Placebo of Probiotics

PLACEBO COMPARATOR

Placebo: Composition: Each capsule contains 560 mg: * 459 mg of corn starch * 6 mg of magnesium stearate Dosage: 2 capsules / day, in the morning at sunrise, one at bedtime. Methods of administration: Oral. Duration of treatment: 14 days

Dietary Supplement: Placebo

Probiotics- Lactibiane Tolerance

ACTIVE COMPARATOR

Active substance mixture of lactic 10% Bifidobacterium lactis LA 303, 10% Lactobacillus acidophilus LA 201, LA 40% Lactobacillus plantarum 301, 20% Lactobacillus salivarius LA 302, LA 20% Bifidobacterium lactis 304 Dosage: 10 X 10\^9 probiotic / capsule Composition: One capsule of 560 mg contains Lactibiane tolerance: * 345 mg of corn starch * 114 mg premix lactic * 6 mg of magnesium stearate Excipients: magnesium stearate Method of administration: Oral Dosage: 2 capsules per day for 14 days in two doses: one capsule at sunrise, one capsule at bedtime;

Dietary Supplement: Probiotic

Interventions

Probiotic DIETARY_SUPPLEMENT

Lactibiane TOLERANCE vs Placebo

Also known as: Lactibiane TOLERANCE (PILeJe) 5 probiotics association

Probiotics- Lactibiane Tolerance

Placebo DIETARY_SUPPLEMENT

Placebo of Probiotics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Agreement signed by the patient
• Diagnosis of HCC confirmed
• Diagnosis of liver disease (score F3 or F4) confirmed
• Indication of surgical resection confirmed and validated by a specialist multidisciplinary assessment meeting of gastrointestinal oncology
• Patient operable (no indication against anaesthesiological)
• Resectable tumor lesion (surgical expertise)
• Laboratory tests and endoscopy: No suspicion of severe portal hypertension with bleeding risk

You may not qualify if:

• Patient not willing, at risk of default of compliance, or patient can not be monitored regularly
• Antibiotic extended or terminated for less than 1 month, may limit the effects of taking probiotics.
• Inflammatory Bowel Disease, which could skew the results expected by taking probiotics results.

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

University Hospital

Rouen, Haute Normandie, 76000, France

Location

Related Publications (1)

• Roussel E, Brasse-Lagnel C, Tuech JJ, Montialoux H, Papet E, Tortajada P, Bekri S, Schwarz L. Influence of Probiotics Administration Before Liver Resection in Patients with Liver Disease: A Randomized Controlled Trial. World J Surg. 2022 Mar;46(3):656-665. doi: 10.1007/s00268-021-06388-7. Epub 2021 Nov 26.

  PMID: 34837121 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis; Carcinoma, Hepatocellular; Endotoxemia

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Bacteremia; Sepsis; Infections; Toxemia; Systemic Inflammatory Response Syndrome; Inflammation

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Lilian Schwarz, MD

  DRCI Rouen

  STUDY DIRECTOR

• Emmanuel Huet, MD

  DRCI Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2013
• First Posted: December 27, 2013
• Study Start: April 1, 2013
• Primary Completion: April 12, 2018
• Study Completion: April 12, 2018
• Last Updated: May 15, 2018

Record last verified: 2018-05

Locations

FR (1)